Status:
UNKNOWN
Primary Prophylaxis for Variceal Bleed in Biliary Atresia
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
Portal Hypertension, Biliary Atresia
Eligibility:
All Genders
6-5 years
Phase:
NA
Brief Summary
Biliary atresia is the commonest etiology of neonatal cholestasis and is the most common indication for pediatric liver transplantation world-wide. Kasai-portoenterostomy (KPE) is the operative proced...
Detailed Description
(a) Aim and Objectives: Aim: To study the effect of beta-blockers for primary prophylaxis of variceal bleed in infants and children with biliary atresia. Primary objective: Bleeding free survival ov...
Eligibility Criteria
Inclusion
- Infants and children with biliary atresia from 6 months to 5 years of age fulfilling either of the following conditions:
- i. With unsuccessful Kasai portoenterostomy procedure with a bilirubin \>2 mg/dL, or ii. Who did not underwent Kasai portoenterostomy, or iii. With successful Kasai portoenterostomy procedure with a bilirubin \<2 mg/dL, but with features of portal hypertension i.e. clinical splenomegaly and/or thrombocytopenia (platelets \< 1,00,000/mm3).
Exclusion
- i. History suggestive of hyper-reactive airway disease. ii. Congestive heart failure iii. Any degree of heart block (I,, II, III) iv. Infants and children already on beta-blockers in last 4 weeks. v. Portal vein atresia or thrombosis. vi. History of variceal bleed. vii. Infants and children on prophylactic or therapeutic endotherapy (band ligation or sclerotherapy).
- viii. Potential liver transplant within 1 month.
Key Trial Info
Start Date :
August 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 15 2022
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT04494763
Start Date
August 15 2020
End Date
June 15 2022
Last Update
March 18 2021
Active Locations (1)
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1
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, India, 110070